DICOM Grid (dba Ambra Health)
Raleigh, NC, US
DICOM Grid (dba Ambra Health) appears in FDA device records in Raleigh, NC. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to DICOM Grid (dba Ambra Health) carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Dicom Grid, Inc.510(k), enforcement report, recall
- DICOM Grid, Inc. d/b/a Ambra Healthenforcement report, recall
510(k) clearance history
FDA records hold 2 510(k) clearances for DICOM Grid (dba Ambra Health) between 2016 and 2023. The busiest year on record is 2016, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2023 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008776294 | 3008776294 | DICOM Grid (dba Ambra Health) | 305 Church at North Hills St, Raleigh, NC 27609 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0941-2026 | Intelerad InteleShare software, with ProViewer component | Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up. | Class II | Open, Classified | |
| Z-1818-2022 | Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images. | A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study. | Class II | Open, Classified | |
| Z-1045-2017 | Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images. | A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain